CLSI QMS06—Quality Management System: Continual Improvement includes written and graphic descriptions of fundamental processes and common supporting elements in a continual improvement program. It provides the user with definitions, concepts, models, and tools for implementing an effective program. The fundamental processes include identifying opportunities for improvement, selecting an opportunity, generating solution(s), implementing solution(s), evaluating the effect of the solution(s), and integrating and sustaining improvement(s). These processes are supported by common elements of management review, teamwork, improvement models and tools, documents and records, change management, risk management, and communication.

CLSI QMS06-Ed4 was revised in 2025 under the Limited Revision Process and replaces CLSI QMS06-A3, which was published in 2011. Several changes were made in this edition, including: 
• Revising the Foreword and Terminology sections to match the current template 
• Removing definitions that are now housed in the Quality Glossary 
• Updating references to CLSI documents and inserting references to new CLSI documents not available when CLSI QMS06 was originally published

CLSI QMS06 includes written and graphic descriptions of the fundamental processes and common supporting elements in a continual improvement (CI) program. It provides the user with definitions, concepts, methods, and tools for implementing an effective program and meeting applicable requirements. The CI fundamental processes include: 
• Identifying opportunities for improvement (OFIs) 
• Selecting an opportunity 
• Generating solution(s) 
• Implementing solution(s) 
• Evaluating the effect of the solution(s) 
• Integrating and sustaining improvement(s) 
The CI common supporting elements include but are not limited to: 
• Management review 
• Teamwork 
• Improvement models and tools 
• Documents and records 
• Change management 
• Risk management 
• Communication 

Although quality professionals might differ on various CI definitions, concepts, models, and tools, CLSI QMS06 attempts to consolidate the vast amount of information available while remaining nonprescriptive. CLSI QMS06 encourages using an organized systematic approach to CI, so that optimal outcomes are achieved for the efforts expended. 

CLSI QMS06 is intended for use by all organizations and individuals involved in the management or implementation of preexamination, examination, and postexamination phases of medical laboratory examinations. CLSI QMS06 may also be applicable to other laboratories and nonlaboratory settings. 

CLSI QMS06 is not meant to be prescriptive, nor a comprehensive instructional manual for using the tools described. It does not cover content and detail covered in other CLSI documents or requirements specific to any regulatory or accreditation organization.